EBVPhase 1NCT07557602
mRNA Vaccine Targeting Epstein-Barr Virus (EBV) in Healthy Young Adults
A Phase 1 study testing VXCO-102 in people with EBV, run by Vaccine Company, Inc, a wholly owned subsidiary of Eli Lilly and Company at 2 sites in Australia.
Trial summary
This is a Phase 1 clinical trial to evaluate the safety and immunogenicity of VXCO-102 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- EBV
- What is being tested?
- VXCO-102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 2 sitesAustralia
- Study dates
- 16 Nov 2026to 29 Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 25 years, inclusive
- Healthy per medical assessment based on self-reported medical history, physical examination, vital signs, and laboratory assessment
Who cannot join
- Self-reported or medically-documented significant medical or psychiatric condition that per medical assessment could interfere with study participation
- Likely or confirmed myocarditis or pericarditis
- Prior receipt of an investigational EBV vaccine
- Prior receipt of a licensed vaccine within 56 days prior to Day 1
- Received more than 10 days of any systemic immunosuppressants or cytotoxic medications within 56 days prior to Day 1, any within 14 days prior to Day 1, or will need immunosuppressants at any time during the study.
- For participants of childbearing potential: pregnant, breastfeeding or planning to become pregnant during the study
- Note: Other inclusion and exclusion criteria apply.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Q-Pharm Pty Ltd/Nucleus Network Pty Ltd
Herston, Queensland, 4006
- Recruiting
Nucleus Network Pty Ltd
Melbourne, Victoria, 3004
About this study
Official title: A Phase 1, Dose Escalation, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of VXCO-102, a mRNA Vaccine Targeting Epstein-Barr Virus (EBV) in Healthy Young Adults
This is a Phase 1 clinical trial to evaluate the safety and immunogenicity of VXCO-102 in healthy adult participants.
Read the detailed description
This first-in-human, dose-escalation Phase 1 trial evaluates the safety, tolerability, and immunogenicity of VXCO-102 in healthy young adults across multiple sites in Australia.
The trial will enroll up to 90 participants aged 18-25. After sentinel safety review in each dose cohort, participants will be randomized to receive VXCO-102 or placebo, with a booster at Week 8.
All participants will undergo ongoing safety monitoring and immune response assessments through clinical evaluations, sample collection, and participant reporting.
- Conditions
- EBV
- Being tested
- VXCO-102, Placebo
- Keywords
- EBV, vaccine, mRNA, first in human, Epstein-Barr virus
- Medical subject headings
- Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VXCO-102Biological
Sterile liquid for injection
PlaceboBiological
0.9% sodium chloride (BP grade)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Dose 1 - VXCO-102 administered IM by needle and syringe at Day 1 and Week 8 Receives: Biological: VXCO-102 |
| Group 2 | Experimental | Dose 2 - VXCO-102 administered IM by needle and syringe at Day 1 and Week 8 Receives: Biological: VXCO-102 |
| Group 3 | Experimental | Dose 3 - VXCO-102 administered IM by needle and syringe at Day 1 and Week 8 Receives: Biological: VXCO-102 |
| Placebo | Placebo comparator | Sodium Chloride administered IM by needle and syringe at Day 1 and Week 8 Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Solicited Local and Systemic Reactions
Measured: 7 days after each product administration
Number of Participants with Unsolicited Adverse Events
Measured: Up to 28 days after each product administration
Number of Participants with Serious Adverse Events (SAEs) including Suspected Unexpected Serious Adverse Reactions (SUSARs) and Adverse Events of Special Interest (AESIs)
Measured: Day 1 to end of study (Day 357)
Secondary outcomes (1)
Rate and Magnitude of Neutralizing Antibody Responses
Measured: Day 1 and 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start16 Nov 2026 (estimated)
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EBVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Dose escalation in sentinels per dose cohort followed by blinded randomization to a dose cohort or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vaccine Company, Inc, a wholly owned subsidiary of Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557602
- Sponsor's protocol ID
- VC103
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Dose Escalation, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of VXCO-102, a mRNA Vaccine Targeting Epstein-Barr Virus (EBV) in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT07557602
- Acronym / sponsor ID
- VC103
- Conditions
- EBV
- Keywords
- EBV, vaccine, mRNA, first in human, Epstein-Barr virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Vaccine Company, Inc, a wholly owned subsidiary of Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2026 (estimated)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 clinical trial to evaluate the safety and immunogenicity of VXCO-102 in healthy adult participants.
Detailed description
This first-in-human, dose-escalation Phase 1 trial evaluates the safety, tolerability, and immunogenicity of VXCO-102 in healthy young adults across multiple sites in Australia.
The trial will enroll up to 90 participants aged 18-25. After sentinel safety review in each dose cohort, participants will be randomized to receive VXCO-102 or placebo, with a booster at Week 8.
All participants will undergo ongoing safety monitoring and immune response assessments through clinical evaluations, sample collection, and participant reporting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Dose escalation in sentinels per dose cohort followed by blinded randomization to a dose cohort or placebo.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: VXCO-102Dose 1 - VXCO-102 administered IM by needle and syringe at Day 1 and Week 8 |
| Group 2 | Experimental | Biological: VXCO-102Dose 2 - VXCO-102 administered IM by needle and syringe at Day 1 and Week 8 |
| Group 3 | Experimental | Biological: VXCO-102Dose 3 - VXCO-102 administered IM by needle and syringe at Day 1 and Week 8 |
| Placebo | Placebo comparator | Biological: PlaceboSodium Chloride administered IM by needle and syringe at Day 1 and Week 8 |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 18 to 25 years, inclusive
- Healthy per medical assessment based on self-reported medical history, physical examination, vital signs, and laboratory assessment
Key exclusion criteria (7 listed)
- Self-reported or medically-documented significant medical or psychiatric condition that per medical assessment could interfere with study participation
- Likely or confirmed myocarditis or pericarditis
- Prior receipt of an investigational EBV vaccine
- Prior receipt of a licensed vaccine within 56 days prior to Day 1
- Received more than 10 days of any systemic immunosuppressants or cytotoxic medications within 56 days prior to Day 1, any within 14 days prior to Day 1, or will need immunosuppressants at any time during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VXCO-102Sterile liquid for injection | Biological | Group 1, Group 2, Group 3 |
| Placebo0.9% sodium chloride (BP grade) | Biological | Placebo |
Primary outcome
Number of Participants with Solicited Local and Systemic Reactions
Time frame: 7 days after each product administration
Number of Participants with Unsolicited Adverse Events
Time frame: Up to 28 days after each product administration
Number of Participants with Serious Adverse Events (SAEs) including Suspected Unexpected Serious Adverse Reactions (SUSARs) and Adverse Events of Special Interest (AESIs)
Time frame: Day 1 to end of study (Day 357)
1 secondary outcome
Rate and Magnitude of Neutralizing Antibody Responses
Time frame: Day 1 and 85
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VXCO-102 in people with EBV, run by Vaccine Company, Inc, a wholly owned subsidiary of Eli Lilly and Company at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Chang ((+61) 3 8593 9801, melbourne@nucleusnetwork.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Solicited Local and Systemic Reactions (time frame: 7 days after each product administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.